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A study of Adverse drug reactions due to platinum based chemotherapy in cancer patients.

An Observational Study for the Assessment of Adverse Drug Reactions of Platinum-Based Chemotherapy in Cancer Patients at Department of Medical Oncology, SMS Hospital, Jaipur.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/05/052883
Enrollment
100
Registered
2023-05-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C801- Malignant (primary) neoplasm, unspecified

Interventions

None listed

Sponsors

Department of Pharamcology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All the confirmed cases of cancer of all age groups and either sex receiving platinum-based chemotherapy and presenting with ADRs at the Department of medical oncology. 2. Patients willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients taking alternative medicine such as Ayurveda, Homeopathy, Siddha, and Unani along with chemotherapy and presenting with ADRs. 2. ADRs caused by other chemotherapeutic agents other than platinum-based. 3. Patients receiving other drugs causing nephrotoxicity, hepatic dysfunction, and myelosuppression.

Design outcomes

Primary

MeasureTime frame
1.Causality assessment- the proportion of cases in various categories (certain, probable, possible) 2.Severity assessment- the proportion of cases in various categories (mild, moderate, severe) 3.Preventability assessment- the proportion of cases in various categories (Definitely preventable, probably preventable, not preventable)Timepoint: 24 weeks—

Secondary

MeasureTime frame
4. Outcome of ADRs- recovered, recovering, not recovered 5. Pattern of ADRs- Organ system affected Timepoint: 6 months—

Countries

India

Contacts

Public ContactDr ASHISH SHARMA

SMS Medical College Jaipur.

jaincharujaincharu2007@gmail.com9829269332

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026