Evidence map›Paper›PMID 27721535›Full record

Observational studyIndian journal of pharmacology

Adverse drug reaction profile of microtubule-damaging antineoplastic drugs: A focused pharmacovigilance study in India.

Hasitha Diana Manohar, Shalini Adiga, Joseph Thomas, Ajitha Sharma

Abstract readObservational Study
In one paragraph

Observational study in Indian journal of pharmacology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Hasitha Diana ManoharDepartment of Pharmacology, Karpaga Vinayaga Institute of Medical Sciences and Research, Dr. M. G. R. Medical University, Chennai, Tamil Nadu, India.
Shalini AdigaDepartment of Pharmacology, Kasturba Medical College, Manipal University, Manipal, Karnataka, India.
Joseph ThomasDepartment of Medical Oncology, Kasturba Medical College, Manipal University, Manipal, Karnataka, India.
Ajitha SharmaDepartment of Pharmacology, Pondicherry Institute of Medical Sciences, Puducherry, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim of the study was to analyze the adverse drug reaction (ADR) profile of microtubule-damaging antineoplastic drugs (taxanes and vinca alkaloids) and to look for unexpected ADRs among the local population. Focused study on these drugs, rampantly used in oncology department for a wide variety of tumors including early and advanced malignancies, would enable better treatment care by physicians. MATERIALS AND

methodsData on ADRs were collected from the cancer patients belonging to both gender and of all ages, on taxanes- or vinca-based cancer chemotherapy and reported in the Indian Pharmacopoeia Commission form. Causality was assessed using the WHO criteria and Naranjo's Algorithm. Preventability and severity of ADRs were also assessed.

resultsA total of 97 ADRs were reported among 488 patients on microtubule-damaging anticancer drugs admitted over a period of 1 year. The incidence rate was 19.87%. Gastrointestinal system (40.2%) was the most affected followed by bone marrow (33%) and skin (8.2%). The highest incidence of ADRs was reported among paclitaxel (54.6%), and vincristine (39.2%). Most of the reported ADRs were of milder nature and preventable. The WHO causality assessment scale indicated 71.1% possible reactions.

conclusionsThis study showed that most ADRs are preventable with effective ADR monitoring. There is a great need to create awareness among healthcare professionals regarding the importance of the pharmacovigilance system. Judicious use of the preventive measures will lead to a reduction in the incidence of ADRs due to the drug armamentarium, thereby enabling additional economic benefit to the patient and society.

Indexed as

AdultAntineoplastic AgentsDrug-Related Side Effects and Adverse ReactionsFemaleHumansIncidenceIndiaMaleMicrotubulesMiddle AgedPharmacovigilanceTaxoidsVinca AlkaloidsAntineoplastic AgentsTaxoidsVinca AlkaloidsAdverse drug reactionsfocused pharmacovigilancetaxanesvinca alkaloids

Identifiers

PMID27721535
PMCPMC5051243

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.